NCT00496392

Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Nycomed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary: • To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients. Secondary: * To compare patients' general impression and preference of NF and Actiq * To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid * To assess safety and tolerability of NF

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Nasal fentanyl	Breakthrough pain in patients with breast or prostate cancer

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-08-01
• Completion: 2009-10-01
• First posted: 2007-07-04
• Last updated: 2012-05-07

Locations

1 site across 1 country: Denmark